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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT01234389 |
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Date of registration:
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02/11/2010 |
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Primary sponsor: |
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Public title:
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Immediate Detection of Helicobacter Infection With a New Electrochemical System.
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Scientific title:
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Immediate Detection of Helicobacter Infection With a New Electrochemical System |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01234389 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Germany
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Contacts
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Name:
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Markus F. Neurath, M.D., Ph.D. |
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Address:
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Telephone:
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4991318535204 |
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Email:
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markus.neurath@uk-erlangen.de |
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Affiliation:
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Name:
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Markus F. Neurath, M.D., Ph.D. |
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Address:
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Telephone:
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4991318535204 |
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Email:
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markus.neurath@uk-erlangen.de |
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Affiliation:
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Name:
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Helmut Neumann, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Erlangen-Nuremberg |
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Name:
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Markus F. Neurath, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Erlangen-Nuremberg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical
trial
- Subjects undergoing EGD
Exclusion Criteria:
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time >
50 s)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Residing in institutions (e.g. prison)
- PPI intake
- antibiotic use, actual or within the last 4 weeks
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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H. Pylori Infection
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Intervention(s)
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Device: C13-urea breath test
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Device: Electrochemical H. pylori detection method
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Device: HUT
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Device: IHC
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Primary Outcome(s)
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Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
[Time Frame: Oktober 2009 - February 2011]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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